Risk Management File - Procedure Packs

StepPCHen

Starting to get Involved
#1
Good afternoon,

I have a question surrounding the Risk Management File.

We are Manufacturers of Sterile Single Use Procedure Packs. Do we need a Risk Management File for each Device? Or is it enough to create a Risk Management for a Procedure Pack as all hazards etc are the same for each Device?
 
Elsmar Forum Sponsor

Tidge

Trusted Information Resource
#2
It is common that "families" of devices leverage a common set of RM files... be sensitive to the possibility that different members of a family may have different Severity Ratings/P1/P2, Risk Controls, Implementations and Measures of Effectiveness, and that you didn't "forget" to provide coverage (in the RM files) for all members of the family.

In this case, you probably need to make sure that the sterilization methods are appropriate for all members of the family and provide equivalent measures of risk controls, even if there are only a handful of "lines" in the RM file for certain hazards relating to infection.
 

ChrisM

Involved In Discussions
#3
Surely you can produce one Risk Management File with the relevant documents addressing the range of products? So long as each is mentioned and any differences identified, I cannot see why this would be unacceptable. There's nothing in the Standards/Regulations that I am aware of that states that any RM document has to be unique to a single product
 

ThatSinc

Involved In Discussions
#4
Note: My response is solely around EU requirements on procedure packs.

My understanding of procedure packs is that they are collations of devices that already bear the CE marking with an intended use of their own, that are intended to be used together.
Whilst the definition in the MDR

‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;

is vague enough that it could be considered that any combination of products packaged together could be a procedure pack without having been assessed as a device anyway, Article 22(4) clarifies that.

4. Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manufacturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers.


As such I would expect each device in a procedure pack to have its own risk file anyway - and the relevant declaration regarding the procedure pack drawn up in line with this.
I would personally find that preparing a risk file for each device within the procedure packs in isolation and then a verification of compatibility exercise more comprehensive and, whilst likely more administration, far easier to manage.


I've not prepared risk files for procedure packs I've been a part of placing on the market before and never had any issues - though this has only been a handful of packs at a handful of manufacturers.
 
Thread starter Similar threads Forum Replies Date
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
A Defining Expected Service Life in Risk Management File Reliability Analysis - Predictions, Testing and Standards 5
S Medical Device Cybersecurity Risk Management File ISO 14971 - Medical Device Risk Management 2
M Risk Management File for Extra Oral RX Equipment ISO 14971 - Medical Device Risk Management 11
G Risk Management file for EN 60601-1 3rd test ISO 14971 - Medical Device Risk Management 3
D CAPA FDA Requirements and Guidance related to the Risk Management File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B Define Fault, Double Fault and Normal Conditions - Preparing a Risk Management File FMEA and Control Plans 1
V ISO 14971: 2007 Risk Management File - Separate file required for each product? ISO 14971 - Medical Device Risk Management 3
S Technical & Risk Management File - Subcontract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
B Risk Management Procedure updates needed for 14971:2019 ISO 14971 - Medical Device Risk Management 1
M Intended Use vs Actual Use and Scope of Risk Management EU Medical Device Regulations 8
S IDCB 0129/0160 Clinical Risk Management ISO 14971 - Medical Device Risk Management 2
A Risk Management Team IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
G Risk Management for IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
K Do you have separate clinical risk management group or experts in your manufactures? EU Medical Device Regulations 4
Sidney Vianna ISO Practical Guide on ISO 31000:2018 - Risk Management Other ISO and International Standards and European Regulations 0
T Risk Assessment and Management Misc. Quality Assurance and Business Systems Related Topics 0
J HELP NEEDED ! Risk Management Exercise ISO 14971 - Medical Device Risk Management 12
O Should a Covid vaccine and testing policy be included as part of ISO9001 or AS9100 risk management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Melissa Risk Management Process, How far do I need to go? ISO 14971 - Medical Device Risk Management 13
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
H Risk Management Plan in agile process ISO 14971 - Medical Device Risk Management 14
U Supply risk management Manufacturing and Related Processes 4
T Biological Evaluation (10993) & Risk Management ISO 14971 - Medical Device Risk Management 9
D Cybersecurity and Risk Management: Loss of confidentiality IEC 62304 - Medical Device Software Life Cycle Processes 5
S Risk Management Review ISO 14971 - Medical Device Risk Management 4
S Risk Management and other Files ISO 14971 - Medical Device Risk Management 8
silentmonkey Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation ISO 14971 - Medical Device Risk Management 3
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
Sravan Manchikanti Software Risk Management & probability of occurrence as per IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
T How do you define your Hazards? <a Risk Management discussion> ISO 14971 - Medical Device Risk Management 16
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
C AS9100 Rev D 8.1.1 & APQP - Operational risk management process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B ATP 5-19 "Risk Management" Misc. Quality Assurance and Business Systems Related Topics 2
N Risk Management besides mandated FDA requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Identifying Hazards - Risk management process ISO 14971 - Medical Device Risk Management 6
R Risk Management in the Medical Device Industry ISO 14971 - Medical Device Risk Management 4
F Linking an ISO 31000 Risk management SOP to ISO 17025 ISO 17025 related Discussions 2
Ronen E The unbearable insensitivity of risk management language Other Medical Device and Orthopedic Related Topics 1
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
M Risk/Benefit vs. benefit-risk - Revising an SOP covering Risk Management with the MDR in mind EU Medical Device Regulations 10
R Linking the Processes of Continual Improvement, Change Management, Risk Management, Action Planning, etc? Preventive Action and Continuous Improvement 5
D Risk management according to ISO 14971 - When to document risk controls? ISO 14971 - Medical Device Risk Management 10
J Software for Techfiles and Risk management ISO 14971 - Medical Device Risk Management 1
M Informational ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019 Medical Device and FDA Regulations and Standards News 6
M Medical Device News ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019 Medical Device and FDA Regulations and Standards News 0
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13

Similar threads

Top Bottom